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CTRI Number  CTRI/2025/04/084897 [Registered on: 16/04/2025] Trial Registered Prospectively
Last Modified On: 16/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to compare preoperative administration of pregabalin and duloxetine for postoperative pain  
Scientific Title of Study   Comparison of preoperative administration of pregabalin and duloxetine for postoperative pain  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gurpreeti Kaur 
Designation  Associate Professor  
Affiliation  Dayanand Medical College and Hospital  
Address  Department of anaesthesiology Dayanand Medical College and hospital Ludhiana Punjab

Ludhiana
PUNJAB
141001
India 
Phone  9779552017  
Fax    
Email  grewal.preeti@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manpreet Kaur 
Designation  PG resident anaesthesia  
Affiliation  Dayanand medical college and hospital Ludhiana Punjab  
Address  Department of anaesthesiology Dayanand Medicall college and hospital Ludhiana Punjab 141001

Ludhiana
PUNJAB
141001
India 
Phone  7985357174  
Fax    
Email  mkaur2585@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manpreet Kaur  
Designation  PG resident Anaesthesia  
Affiliation  Dayanand medical college and hospital Ludhiana Punjab 141001 
Address  Department of anaesthesiology Dayanand medical college and hospital Ludhiana Punjab

Ludhiana
PUNJAB
141001
India 
Phone  7986357174  
Fax    
Email  mkaur2585@gmail.com  
 
Source of Monetary or Material Support  
Dayanand medical college and hospital Ludhiana Punjab India 141001 
 
Primary Sponsor  
Name  Dayanand medical college and hospital Ludhiana Punjab  
Address  Tagore nagar Civil Lines Ludhiana Punjab India 141001 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gurpreeti Kaur  Dayanand medical college and hospital   Department of anaesthesiology Dayanand medical college and hospital Civil Lines Tagore nagar Ludhiana Punjab 141001
Ludhiana
PUNJAB 		 9779552017

grewal.preeti@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethical committee Dayanand medical college and hospital Ludhiana Punjab  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cap Duloxetine 60 mg  60 mg of capsule Duloxetine orally one hour prior to the surgery for VAS assessment for 24 hrs 
Comparator Agent  Cap Pregabalin 75 mg  75 mg of capsule Pregabalin orally one hour prior to the surgery for VAS assessment for 24 hrs 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. ASA grade I-III patients
2. Adult patients (18-65 years)
3. Either gender
4. Patients scheduled for laparoscopic cholecystectomy under general anaesthesia. 
 
ExclusionCriteria 
Details  1. Patient with known allergy to any of the study drug
2. ASA grade IV or more
3. Patients with underlying psychiatric disorders
4. Patients on antiepileptics or MAO inhibitors
5. Patients on chronic pain medications
6. Patients with H/O SIADH
• Patients with H/O syncope
• Lactating and pregnant females
• Patient refusal
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the analgesic efficacy of oral Pregabalin and Duloxetine using VAS score   VAS score at PACU at 0 minutes (on shifting to PACU), 1, 2, 4, 8, 12, 24 hours postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the consumption of total rescue analgesic in first 24 hours postoperatively
2. Postoperative sedation using five point NSS scale
3. The frequency of postoperative nausea & vomiting using four point PONV Scale  		 Postoperative sedation & postoperative nausea & vomiting at 0 min(on shifting to PACU) 1, 2,4,8,12,24 hours.Time to first rescue analgesia & total amount of rescue analgesia required in first 24 hours postoperatively  
 
Target Sample Size   Total Sample Size="260"
Sample Size from India="260" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="29" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The pain pattern after laparoscopic cholecystectomy is complex and distinct from postoperative pain after other laparoscopic procedures, suggesting that procedure specific optimal analgesic management plans should be proposed. Duloxetine is a SNRI  which is being used as an adjunct for management of neuropathic pain and attenuation of postoperative pain especially in lower limb surgeries. Pregabalin ,a structural analogue of GABA , reduces opioid consumption and postoperative pain after major surgeries. However, the comparison of these drugs on global postoperative quality of recovery in laparoscopic surgeries has yet to be evaluated. An interventional randomised study will be conducted in 260 adult patients of American Society of Anesthesiologists(ASA) grade I-III aged 18-65 years scheduled for laparoscopic cholecystectomy under general anesthesia who will be randomly and equally divided into two groups I,II. Group I 130 patients will be administered preoperatively 75 mg of capsulePregabalin orally and group II 130 patients 60 mg of capsule Duloxetine orally one hour prior to the surgery. Postoperative analgesic efficacy will be compared in both the two groups by using VAS score at 0 min, 1,2,4,8,12,24 hours along with assessment of sedation using Numeric Sedation Scale at 0,1,2,4,8,12 and 24 hours, time to first rescue analgesia and total amount of rescue analgesia required in first 24 hours. 
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